What are the changes in 5th Edition of FMEA manual?

Highly Rated Gage Tracking - Learn More
Elsmar Forum Sponsor
Jimmy123

Jimmy123

Involved In Discussions
#3
#3
The 5th edition, is the 1st edition. The core method is still the same. Same questions has to be answered. Instead of 120 possible RPN’s you have now 3 classes of action priorities. High, Medium and Low. In my opinion the description of the tables are unclear. You can find some ratings with L and anyway high risks for a customer complain. S= 10 is for safety, and S=9 for governance effects. Indicator doesn’t work is it 9 or 10? You can get a ticket or you can get an accident, if the indicator doesn’t work. If you cut the skin, if you loss the finger or if you loss the arm or your life all is S=10.
 
B

Bill Levinson

Industrial Statistician and Trainer
#5
#5
Jimmy123 said:
The 5th edition, is the 1st edition. The core method is still the same. Same questions has to be answered. Instead of 120 possible RPN’s you have now 3 classes of action priorities. High, Medium and Low. In my opinion the description of the tables are unclear. You can find some ratings with L and anyway high risks for a customer complain. S= 10 is for safety, and S=9 for governance effects. Indicator doesn’t work is it 9 or 10? You can get a ticket or you can get an accident, if the indicator doesn’t work. If you cut the skin, if you loss the finger or if you loss the arm or your life all is S=10.
Click to expand...
I remember expressing a concern when it was being developed that you can get a Low rating for a failure mode that involves a 9 or 10 severity rating, which was not previously possible. Even if you got a RPN of 9 or 10, it required attention. If I look at page 208, it looks like you can in fact get a Low action priority as long as the Frequency and Monitoring ratings are low (good) enough.

The Army's Risk Management process has four risk levels, and it is impossible to get a Low rating for the highest severity category.
 
B

Bill Levinson

Industrial Statistician and Trainer
#7
#7
Marc said:
Where to get a copy?
Click to expand...
It's public domain as a publication of the U.S. Government. I'll add it as a free resource too.

It brings up a point not raised in FMEA; that the risk of occurrence (ATP 5-19 calls it frequency) isn't just the individual chance of occurrence, it also reflects the frequency with which we are exposed to the risk, e.g. how many times we do the job, or how many parts we make.
 

Attachments

You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
Sidney Vianna IAQG News IAQG 9401-1:2022 Changes & Organization Certification Analysis Process - OCAP Demo AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 0
T Changes to product IFU & Summative Testing IEC 62366 - Medical Device Usability Engineering 1
T Changes to Controlled Documents AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
Q Changes to AS9102 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
G Non-significant changes EU Medical Device Regulations 3
Z How to keep up with changes on applicable technical standards (EU MDR)? EU Medical Device Regulations 6
S Turkey- SUT match- GTIN changes caused re-registration Other Medical Device Regulations World-Wide 0
O IATF 16949 News Upcoming Changes to IATF 16949? IATF 16949 - Automotive Quality Systems Standard 4
P Product Requirements Control during Design Changes Design and Development of Products and Processes 4
L ISO 20417 crucial changes Other Medical Device Related Standards 1
Ed Panek 60601-1-11 Changes IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
J Document Changes that don't have to be approved Document Control Systems, Procedures, Forms and Templates 11
M Are we getting scammed by our Notified Body? They are asking to review all changes to determine if they are Significant CE Marking (Conformité Européene) / CB Scheme 4
S What types of changes need to be notified to NBs? Registrars and Notified Bodies 1
Sidney Vianna Informational Changes to Terms and Definitions in ISO/TC 176 Standards since ISO 9000:2015 was issued. ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
Moncia Changes to procedure communication ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
J Changes to OS - Significant change under MDR EU Medical Device Regulations 8
G Significant changes on MDD devices/Old Devices after MDR transitional period EU Medical Device Regulations 2
A Changes in ETSI EN 301-48-17 v3.2.4 2020 Other Medical Device Related Standards 2
J Managing design verification regression testing of design changes Design and Development of Products and Processes 1
D License annual renewal - What changes to report to HC? Canada Medical Device Regulations 1
R What are the new changes in EN ISO 11137-1:2015+A2:2019? Other Medical Device Related Standards 2
A Making changes to IDE device Other US Medical Device Regulations 7
M MD Class I transition period MDD to MDR - changes? EU Medical Device Regulations 1
S IATF 16949 - Summary at a glance Clause wise - changes from ISO TS IATF 16949 - Automotive Quality Systems Standard 4
M Handling design changes with use-as-is inventory disposition Quality Manager and Management Related Issues 6
S Class 1 and 2 changes in CM standards (aerospace industry) Federal Aviation Administration (FAA) Standards and Requirements 0
S Class 1 vs Class 2 changes Federal Aviation Administration (FAA) Standards and Requirements 0
P Interim Order Authorization Changes Canada Medical Device Regulations 0
R Changes vs CMO - How can we simplify this process? Supplier Quality Assurance and other Supplier Issues 3
Ed Panek What are the limits on manufacturing changes and substantial changes? EU Medical Device Regulations 6
F Hospital Rebrand & Name changes Document Control Systems, Procedures, Forms and Templates 4
M IEC 62304 Software changes - Minor labeling changes on the GUI IEC 62304 - Medical Device Software Life Cycle Processes 3
Aymaneh ISO 11607-1: 2019 main changes Other Medical Device Related Standards 2
L Process changes and biocompatibility (ISO 10993-1) Other Medical Device Related Standards 1
E ASTM F2118 - Fatigue testing of bone cement - Changes between the 2003 and the 2014? Other Medical Device Related Standards 1
qualprod Documented actions and changes in the QMS by COVID 19 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
B ASTM E18-2020 - Rockwell testing standard changes? General Measurement Device and Calibration Topics 2
D Recent changes to ISO 14971 - SOP required for managing standard revisions ISO 13485:2016 - Medical Device Quality Management Systems 1
I Dating controlled documents after changes - Revision History Document Control Systems, Procedures, Forms and Templates 13
F Medical Devices - Hong Kong - Post approval changes regulation (China's MOH) Other Medical Device Regulations World-Wide 3
F Medical Devices-South Africa _Post approval changes and Software Other Medical Device Regulations World-Wide 0
K Changes in process dispersion, and location hypotheses tests Using Minitab Software 3
NDesouza When Customers Make Changes to Orders Contract Review Process 24
S Managing specification changes on standard parts purchased through trading companies Document Control Systems, Procedures, Forms and Templates 2
I MSA requirement for 5 Micrometers + CP changes need customer approval? IATF 16949 - Automotive Quality Systems Standard 2
A ISO13485:2016 name and ownership changes questions ISO 13485:2016 - Medical Device Quality Management Systems 3
S Examples of software changes that required a 510k US Food and Drug Administration (FDA) 2
D 510K and Changes to Verification and Validation US Food and Drug Administration (FDA) 2
V IATF 16949 9.2.2.1 Internal Audit Program - "Process Changes" IATF 16949 - Automotive Quality Systems Standard 11

Similar threads

Top Bottom